scholarly journals Bacteriophage Treatment: Critical Evaluation of Its Application on World Health Organization Priority Pathogens

Viruses ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 51
Author(s):  
Raghad Khalid AL-Ishaq ◽  
Sini Skariah ◽  
Dietrich Büsselberg
Keyword(s):  
Bacterial Infections ◽  
Critical Evaluation ◽  
World Health ◽  
Efficacy And Safety ◽  
Regulatory Processes ◽  
Safe Strategy ◽  
Infection Models ◽  
Host Identification ◽  
Health Organization ◽  
Phage Selection

Bacteriophages represent an effective, natural, and safe strategy against bacterial infections. Multiple studies have assessed phage therapy’s efficacy and safety as an alternative approach to combat the emergence of multi drug-resistant pathogens. This systematic review critically evaluates and summarizes published articles on phages as a treatment option for Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Enterococcus faecalis infection models. It also illustrates appropriate phage selection criteria, as well as recommendations for successful therapy. Published studies included in this review were identified through EMBASE, PubMed, and Web of Science databases and were published in the years between 2010 to 2020. Among 1082 identified articles, 29 studies were selected using specific inclusion and exclusion criteria and evaluated. Most studies (93.1%) showed high efficacy and safety for the tested phages, and a few studies also examined the effect of phage therapy combined with antibiotics (17.2%) and resistance development (27.6%). Further clinical studies, phage host identification, and regulatory processes are required to evaluate phage therapy’s safety and efficacy and advance their clinical use.

scholarly journals Management and Treatment of Hepatitis C: Are There Still Unsolved Problems and Unique Populations?

Viruses ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1048
Author(s):  
Virginia Solitano ◽  
Maria Corina Plaz Torres ◽  
Nicola Pugliese ◽  
Alessio Aghemo
Keyword(s):  
Hepatitis C ◽  
Previous Treatment ◽  
World Health ◽  
Current Evidence ◽  
Decompensated Cirrhosis ◽  
Drug Side Effects ◽  
Efficacy And Safety ◽  
Current Scenario ◽  
Health Organization ◽  
Direct Acting

Direct-acting antivirals (DAA) have revolutionized the treatment of patients with chronic hepatitis C virus (HCV) infection, possibly leading to HCV elimination by 2030 as endorsed by the World Health Organization (WHO). However, some patients belonging to the so-called unique or special populations are referred to as difficult-to-treat due to unreached sustained virological response, potential drug side effects or interactions or co-morbidities. Several years after the DAA introduction and on the basis of excellent findings in terms of efficacy and safety, some doubts arise around the exact meaning of the special population designation and whether this group of patients actually exists. The aim of this review is to discuss and analyze current evidence on the management and treatment of the so-called “unique populations”. We placed particular emphasis on patients with decompensated cirrhosis, chronic kidney disease (CKD), coinfections, rare genotypes, and previous treatment failure, in order to provide physicians with an updated overview of the actual problems and needs in the current scenario.

World Health Organization recommendations for multidrug-resistant tuberculosis: should different standards be applied?

2017 ◽  
Vol 21 (12) ◽  
pp. 1211-1213 ◽  
Author(s):  
V. Cox ◽  
J. Furin
Keyword(s):  
World Health Organization ◽  
Safety Data ◽  
Evaluation Process ◽  
Multidrug Resistant ◽  
World Health ◽  
Efficacy And Safety ◽  
Assessment Development ◽  
Resistant Tuberculosis ◽  
Multidrug Resistant Tuberculosis ◽  
Health Organization

The World Health Organization uses a Grading of Recommendations Assessment, Development, and Evaluation process to make recommendations for treating multidrug-resistant tuberculosis. Even with this standardized approach, there have been discrepancies between recommendations for newer drugs such as bedaquiline and delamanid and the shorter regimen. This may be because newer drugs are novel chemical entities and may merit closer scrutiny. Here, we explore the problematic nature of this supposition, arguing that although the newer drugs have been used in fewer individuals, they may have more robust efficacy and safety data than many of the second-line drugs used in the shorter regimen.

scholarly journals The efficacy and safety of interferons for the treatment of patients with COVID-19: protocol for systematic review and meta-analysis of controlled trials

2021 ◽  
Author(s):  
Afsaneh Noormandi ◽  
Mohammad Fathalipour ◽  
Reza Daryabeygi-Khotbehsara ◽  
Soheil Hassanipour
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Meta Analysis ◽  
World Health ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Global Pandemic ◽  
The World ◽  
Health Organization ◽  
Time Of Administration

Background and objective: COVID-19 has since been declared a global pandemic by the World Health Organization (WHO), infecting millions worldwide. The use of Interferon (INF) subtypes previously examined in the treatment of SARS and MERS is also being initiated in some clinical trials. Although different clinical trials were evaluated IFNs in the treatment of COVID-19, their efficacy and safety remain unknown. Therefore, this study aims to systematically assess IFNs efficacy and safety in treating patients with COVID-19. Methods: The protocol has been registered in the PROSPERO International Prospective Register (CRD42020200643) on 24 July 2020. This protocol has been arranged according to the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) 2015 checklist. Discussion: Due to lack of approved medication for the covid-19 treatment and also various mutations of this virus, evaluated the efficacy and safety of medications by various studies could help for finding treatments with high effectiveness. IFNs are one of the medications that have been administered in covid-19 infection.  Moreover, the best time of administration and dose of this medication was unknown. Although meta-analysis is a potent source for assessing the accuracy of subjects, heterogeneity of articles is a potent limitation of our work.

scholarly journals Efficacy and safety of tetramethylpyrazine phosphate on pulmonary hypertension: study protocol for a randomized controlled study

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yuqin Chen ◽  
Wenjun He ◽  
Haiping Ouyang ◽  
Chunli Liu ◽  
Cheng Hong ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Treatment Group ◽  
Phase Iii ◽  
World Health ◽  
Controlled Study ◽  
Stable Phase ◽  
Control Group ◽  
Efficacy And Safety ◽  
Traditional Chinese Herbal Medicine ◽  
Health Organization

Abstract Background Tetramethylpyrazine (TMP), an active ingredient in the traditional Chinese herbal medicine Rhizoma Chuanxiong, has been used clinically for the prevention and treatment of cardiovascular disease. The benefits of TMP are largely attributed to its anti-oxidative and vasodilative properties. However, the efficacy of TMP in the treatment of pulmonary hypertension (PH) is unknown. We hypothesized that TMP may have a therapeutic effect in patients with PH. Methods/design A randomized, single-blinded, clinical study with a TMP treatment group and a control group will be conducted to evaluate the efficacy and safety of TMP intervention in patients with PH. The recruitment target is 120 subjects meeting the following criteria: (i) at rest and at sea level, mean pulmonary artery pressure above 20 mmHg and pulmonary capillary wedge pressure below 15 mmHg; (ii) type 1 or 4 PH in the stable phase; (iii) age 15–70 years; (iv) 6-min walk distance between 100 and 450 m; (v) World Health Organization (WHO) functional classification of pulmonary hypertension of II, III, or IV. Subjects will be assigned randomly into two groups at a ratio of 1:2 (control:TMP). Both groups will receive routine treatment, and the treatment group will also receive oral TMP (100 mg) three times a day for 16 weeks. All patients will be followed up for 4, 8, 12, and 16 weeks; symptoms and patient compliance will be recorded. Discussion We aimed to determine the efficacy and safety of TMP for the treatment of PH. Trial registration Chinese Clinical Trial Register, ChiCTR1800018664. Registered on 2 October 2018.

scholarly journals A Proposal of a Combined Convergence Regulatory Strategy Applied to Post-approval Changes by Latin American Countries, Reducing Workload and Allowing Continuous Improvement to Guarantee the Quality, Safety, and Efficacy of Medicines

2021 ◽  
Vol 8 ◽  
Author(s):  
Heraclio Rodriguez ◽  
Maria Lucia De Lucia
Keyword(s):  
Costa Rica ◽  
Latin American ◽  
Negative Impact ◽  
World Health ◽  
Regulatory Agencies ◽  
Regulatory Pathways ◽  
Regulatory Processes ◽  
Local Decision ◽  
Health Organization ◽  
Latin American Countries

In recent years, post-approval changes (PACs) for medicinal products have increased faster than the national regulatory agencies can attend to without causing any negative impact. This study presents a proposal for regulatory management based on our analysis of the data available from the national regulatory agencies of Latin America on the total post-approval changes evaluated, and the time spent in the process. A retrospective search on the official websites of competent national regulatory authorities (NRAs) of 14 Latin American countries (México, Guatemala, Nicaragua, Honduras, El Salvador, Panamá, Costa Rica, Venezuela, Colombia, Ecuador, Peru, Argentina, Chile and Brazil) was conducted to collect data on post-approval changes in the last 4–6 years, up to January 2021. The NRAs considered were Brazil, México, Colombia, and Costa Rica. Our analysis was focused on the post-approval changes that required approval before implementation, those that were submitted, and those that were submitted and approved for small molecules, biologics, and biotechnological products. The results indicated differences in the regulatory processes and procedures applied by the different agencies. We also found that the implementation of the PACs was directly impacted by limited resources, which puts the medication supply for chronic treatments at risk resulting in serious consequences for patients. For local decision-making, Latin American NRAs should implement regulatory pathways already made by regulatory agencies included in the World Health Organization Listed Authorities on PAC approval to optimize their resources and to ensure the continuity of medicine supply for their patients.

scholarly journals Candidates for treatment of COVID-19: current scenario and way forwards

2020 ◽  
Vol 7 (8) ◽  
pp. 3273
Author(s):  
M. Abu Bashar
Keyword(s):  
Clinical Efficacy ◽  
Clinical Characteristics ◽  
Treatment Options ◽  
Therapeutic Agents ◽  
World Health ◽  
Current Evidence ◽  
Efficacy And Safety ◽  
Control And Prevention ◽  
Current Scenario ◽  
Health Organization

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), has spread across the globe resulting in a pandemic affecting 215 countries. At the time of this review, COVID-19 has been diagnosed in more than 15,000,000 patients and associated with over 1,00,000 deaths globally (Centers for Disease Control and Prevention, World Health Organization). In this review, we herein summarize the current evidence as on May 15, 2020 to provide guidance on potentially beneficial drugs in COVID-19 treatment or prophylaxis, their scientific rationale and their clinical efficacy and safety. New data continue to emerge daily regarding clinical characteristics, treatment options, and outcomes for COVID-19. Optimized supportive care remains the mainstay of therapy, and the clinical efficacy for many potential therapeutic agents is still under investigation.

scholarly journals Analysis of the clinical pipeline of treatments for drug resistant bacterial infections: despite progress, more action is needed

2022 ◽  
Author(s):  
Mark S. Butler ◽  
Valeria Gigante ◽  
Hatim Sati ◽  
Sarah Paulin ◽  
Laila Al-Sulaiman ◽  
...  
Keyword(s):  
Bacterial Infections ◽  
Antibacterial Agents ◽  
Phase 1 ◽  
Clinical Development ◽  
World Health ◽  
Drug Resistant ◽  
Antibacterial Drugs ◽  
Clostridioides Difficile ◽  
Differentiated Candidates ◽  
Health Organization

There is an urgent global need for new strategies and drugs to control and treat multi-drug resistant bacterial infections. In 2017, the World Health Organization (WHO) released a list of 12 antibiotic-resistant priority pathogens and began to critically analyze the antibacterial clinical pipeline. This review analyzes ‘traditional’ and ‘non-traditional’ antibacterial agents and modulators in clinical development current on 30 June 2021 with activity against the WHO priority pathogens, mycobacteria and Clostridioides difficile. Since 2017, 12 new antibacterial drugs have been approved globally, but only vaborbactam belongs to a new antibacterial class. Also innovative is the cephalosporin derivative cefiderocol, which incorporates an iron-chelating siderophore that facilitates Gram-negative bacteria cell entry. Overall, there were 76 antibacterial agents in clinical development (45 traditional and 31 non-traditional) with 28 in Phase 1, 32 in Phase 2, 12 in Phase 3 and four under regulatory evaluation. Forty-one out of 76 (54%) targeted WHO priority pathogens, 16 (21%) against mycobacteria, 15 (20%) against C. difficile and 4 (5%) are non-traditional agents with broad spectrum effects. Nineteen of the 76 antibacterial agents have new pharmacophores and four of these have new modes of actions not previously exploited by marketed antibacterial drugs. Despite there being 76 antibacterial clinical candidates, this analysis indicated that there were still relatively few clinically differentiated antibacterial agents in late-stage clinical development, especially against critical Priority Pathogens. We believe that future antibacterial R&D should focus on the development of innovative and clinically differentiated candidates that have clear and feasible progression pathways to the market.

Obesity as an infectious disease– review of the literature

2015 ◽  
Vol 51 (1) ◽  
pp. 53-58
Author(s):  
Iwona Bil-Lula ◽  
Anna Krzywonos-Zawadzka
Keyword(s):  
Weight Gain ◽  
Environmental Factors ◽  
World Literature ◽  
Bacterial Infections ◽  
Body Weight Gain ◽  
Therapeutic Strategies ◽  
World Health ◽  
The Central Nervous System ◽  
Health Organization ◽  
Intensive Work

Obesity, which is a pathological and excessive accumulation of body fat (WHO; World Health Organization), is the problem undertaken in the world literature for several decades. Significant mortality due to the obesity comorbidities is the basis to undertake an intensive work on the new preventive and therapeutic strategies worldwide. Nevertheless, due to the multifactorial origin of obesity and the growing number of obese subjects, the effectiveness of these strategies appears to be highly limited. Besides to the traditionally recognized etiological factors of obesity, many reports showing an association of infectious agents and uncontrolled weight gain have been published recently. In this paper we present an overview of reports confirming the association between infections and obesity. Data showed that a specific viral and bacterial infections as well as infections with protozoa and prions are associated with the increased intracellular accumulation of lipids, hypertrophy and hyperplasia of adipose tissue, body weight gain, increase of BMI and changes in lipid metabolism. These infections can serve as direct causal agents, but they can also interact with other environmental factors, thus increasing the predisposition to the development of obesity. There are at least a few hypotheses on the pathogenesis of “infectobesity.” There are some reports describing the damage of the central nervous system and hence the endocrine glands dysfunction due to infection, increased insulin susceptibility of infected cells, reduced production and release of leptin, increased glucose and fatty acids transport into adipocytes and inflammatory basis for infectobesity. Undoubtedly, awareness of the relationship between infections and obesity brings us closer to develop the effective preventive and therapeutic strategies, but it also raises the question about other, so far underestimated, environmental factors that increase the predisposition to obesity.

DO POOR ENVIRONMENTAL CONDITIONS DRIVE TRACHOMA TRANSMISSION IN BURUNDI? A MATHEMATICAL MODELLING STUDY

2021 ◽  
pp. 1-14
Author(s):  
D. NDISABIYE ◽  
E. K. WATERS ◽  
R. GORE ◽  
H. SIDHU
Keyword(s):  
Field Data ◽  
World Health ◽  
Improvement Strategy ◽  
Environmental Improvement ◽  
The Poor ◽  
Improvement Factor ◽  
Safe Strategy ◽  
The World ◽  
Health Organization ◽  
Preventable Blindness

Abstract Trachoma is an infectious disease and it is the leading cause of preventable blindness worldwide. To achieve its elimination, the World Health Organization set a goal of reducing the prevalence in endemic areas to less than $5$ % by 2020, utilizing the SAFE (surgery, antibiotics, facial cleanliness, environmental improvement) strategy. However, in Burundi, trachoma prevalences of greater than $5$ % are still reported in 11 districts and it is hypothesized that this is due to the poor implementation of the environmental improvement factor of the SAFE strategy. In this paper, a model based on an ordinary differential equation, which includes an environmental transmission component, is developed and analysed. The model is calibrated to recent field data and is used to estimate the reductions in trachoma that would have occurred if adequate environmental improvements were implemented in Burundi. Given the assumptions in the model, it is clear that environmental improvement should be considered as a key component of the SAFE strategy and, hence, it is crucial for eliminating trachoma in Burundi.

scholarly journals Infection prevention measures for orthopaedic departments during the COVID-2019 pandemic: a review of current evidence

2020 ◽  
Vol 1 (4) ◽  
pp. 74-79 ◽  
Author(s):  
Thomas E. Baldock ◽  
Scott M. Bolam ◽  
Ryan Gao ◽  
Mark F. Zhu ◽  
Michael P. J. Rosenfeldt ◽  
...  
Keyword(s):  
Bacterial Infections ◽  
Close Contact ◽  
World Health ◽  
Current Evidence ◽  
Cochrane Library ◽  
Personal Protection ◽  
Prevention Measures ◽  
Personal Protection Equipment ◽  
Orthopaedic Surgeons ◽  
Health Organization

Aim The coronavirus disease 2019 (COVID-19) pandemic presents significant challenges to healthcare systems globally. Orthopaedic surgeons are at risk of contracting COVID-19 due to their close contact with patients in both outpatient and theatre environments. The aim of this review was to perform a literature review, including articles of other coronaviruses, to formulate guidelines for orthopaedic healthcare staff. Methods A search of Medline, EMBASE, the Cochrane Library, World Health Organization (WHO), and Centers for Disease Control and Prevention (CDC) databases was performed encompassing a variety of terms including ‘coronavirus’, ‘covid-19’, ‘orthopaedic’, ‘personal protective environment’ and ‘PPE’. Online database searches identified 354 articles. Articles were included if they studied any of the other coronaviruses or if the basic science could potentially applied to COVID-19 (i.e. use of an inactivated virus with a similar diameter to COVID-19). Two reviewers independently identified and screened articles based on the titles and abstracts. 274 were subsequently excluded, with 80 full-text articles retrieved and assessed for eligibility. Of these, 66 were excluded as they compared personal protection equipment to no personal protection equipment or referred to prevention measures in the context of bacterial infections. Results There is a paucity of high quality evidence surrounding COVID-19. This review collates evidence from previous coronavirus outbreaks to put forward recommendations for orthopaedic surgeons during the COVID-19 pandemic. The key findings have been summarized and interpreted for application to the orthopaedic operative setting. Conclusion For COVID-19 positive patients, minimum suggested PPE includes N95 respirator, goggles, face shield, gown, double gloves, and surgical balaclava. Space suits not advised. Be trained in the correct technique of donning and doffing PPE. Use negative pressure theatres if available. Minimize aerosolization and its effects (smoke evacuation and no pulse lavage). Minimize further unnecessary patient-staff contact (dissolvable sutures, clear dressings, split casts).

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